AAMI TIR 63 pdf free download

AAMI TIR 63 pdf free download.Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection.
4.5 Scheduling
4.5.1 Delivery
The facility’s policy should specify how long before the procedure the device should be delivered. This should be an agreed-upon time between the relevant departments at the receiving facility and the sender. As much as 48 hours in advance of the procedure may be required.
4.5.2 InformatIon from sender
The sender should communicate the following information to the designated personnel at the receiving facility:
a) expected date and time of arrival of the device.
b) date and time of the in-service for end users and sterile processing personnel, if applicable.
4.5.3 ProcessIng time
The medical device(s) should arrive at the agreed-upon time to allow the receiving facility to follow its procedures for inspecting, inventorying, in-servicing, and reprocessing.
The receiving facility should not accept any medical device that does not arrive in sufficient time to follow its procedures except in a facility-defined emergency.
4.6 Receipt
Defined handling “begins at the loading dock” (i.e., at the point at which the receiving facility assumes responsibility for the loaned device).
The receiving facility’s procedures should address the procedure for receipt, inspection, and preparation of medical devices that are not owned by the facility.
When loaned devices are delivered to the receiving area, personnel should document that according to the packing slip, the correct number of packages have been received. The unopened packaged devices, along with any instwctions for use accompanying the items, should be delivered to the sterile processing area as soon as possible.
To protect individual devices, bulk devices may be stored in shipping cartons in the central receiving area. Loaned devices should be removed from external shipping containers before transport to sterile processing or inspected per the device manufacturer’s written IFU before they enter the sterile storage area.
All loaned devices should be inventoried for completeness and inspected for damage, missing parts, or malfunctions according to the manufacturer’s written IFU. Any devices that do not pass inspection should be returned to the sender for correction prior to use in a procedure.
Prior to use, all loaned medical devices should be reprocessed according to the manufacturer’s written IFU and in accordance with the facility’s policy and procedures.
See also ANSI/AAMI S179.
Rationale: External shipping containers have been exposed to unknown and potentially high microbial contamination.
Also, shipping cartons, especially those made of corrugated material, serve as generators of and reservoirs for dust.
4.7 Return
The receiver should return all devices in working order, provided they were received in working order. The receiver should also replace items not returned.
The facility’s policy should specify how long after the procedure the device will be returned to allow for completion of all reprocessing procedures. The sender should provide sufficient time for the completion of all reprocessing procedures before return by the facility.
Devices potentially exposed to infectious agents not easily inactivated by traditional sterilization should be given extra time before return by the facility.
Before releasing a medical device, the health care facility should decontaminate it in accordance with the manufacturer’s written IFU and ensure that all essential components are present, or communicate in the accompanying documentation any deviation from these requirements.AAMI TIR 63 pdf download.